Disinfectant Qualification Testing for Antiviral Activity

Purpose of Test

An effective disinfection program is critical to assure the quality of the products produced in aseptic processing areas of Good Manufacturing Practice (GMP) facilities. The U.S. FDA requires that, “the suitability, efficacy, and limitations of disinfecting agents and procedures should be assessed. The effectiveness of these disinfectants and procedures should be measured by their ability to ensure that potential contaminants are adequately removed from surfaces.” In order to qualify the disinfection practices and procedure used in these facilities, in-vitro testing may be performed to simulate these practices following the methods and recommendations found in the USP <1072>.

Summary of Test

In this study, representative surfaces found in the GMP manufacturing facility are inoculated with test viruses utilized in the manufacturing production plus any routine viral contaminants isolated by the facility during the manufacturing process. The surfaces are disinfected using the disinfection practices commonly used at the facility. Following treatment, the surfaces are assayed for surviving viruses by an assay method specific for the test virus. The level of reduction deemed necessary for appropriate disinfection is determined by the GMP facility performing the qualification testing.

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